Iqbal Khan

Background

About Iqbal Khan

Process and Cleaning Validation of Pharmaceutical products and equipment - Assessment of cleaning validation and cleaning monitoring practice - Prepare validation protocols and execute per protocol- Risk assessment for the introduction of new source/product/equipment - Investigation of deviation related to manufacturing and cleaning processes- Process and Cleaning Validation of Biologics: Fimbriae antigen of 5-Component Pertussis, Biosimilars, and small molecule active ingredients and formulations- QBD (Quality By Design): CPP, KPP, and NKP. Process design in R&D scale and scale up- Expert in aseptic process validation and sterility assurance of sterile manufacturing- Vaccine Manufacturing technology: Process observation experts such as understanding variability and improvement. Expertise in process criticality and Quality by design- Biopharmaceutical/Biotechnology- Developed recombinant protein technology platform of biopharmaceutical molecules such as Insulin, Interferon, Monoclonal antibodies (mABs), Erythropoietin, Filgrastim, PEG-Interferon, PEG-Filgrastim, PEG-Erythropoetin, etc from R&D to commercial production.Biosimilars- Designed and established research, pilot process, and commercial production of bulk and formulation of Biosimilars (as mentioned above): the first GMP-compliant platform in Bangladesh.Diagnostic- Developed method and design for typhoid detection kit which has been submitted for US Patent approval.Biomedical and biomaterial- Designed and established research and pilot production facility for biomaterial formulations (such as collagen dressing).Pharmaceutical- Led Product Development and Quality Assurance team to develop Sprinkles (5 components and 15 components formulations), a WHO-approved micronutrient oral product financed by GAIN- Well-versed in Global Regulatory and Compliance requirements (GLP, WHO, cGMP, GXP, ICH, EUGMP, EMEA, 21CFR Part 210 & 211, PIC/S, ISO9001-2008, ISO14001, ISO2859, HACCP), Self-inspection and Quality Auditing, Vendor assessment and Sourcing, GMP Training and CAPA Program.